MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ACET SHELL 52MM MULTI; PROSTHESIS, HIP

Catalog Number	00620205220
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the surgery, the surgeon attempted to insert the liner into cup, but it would not lock into place.The surgeon used a new cup and liner, and the procedure was completed successfully.There were no known impact or consequences to the patient.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: g3; h2; h3; h6.Visual examination of the returned product identified the lock ring able to be rotated within the lock ring groove slightly.Due to the top rim surface being bent the lock ring is not able to be removed and movement is restricted.There are gouges around the i.D.And rim of the shell as well as on the lock ring.There are nicks and scratches on the top flat surface and alignment post of the shell as well.No other damage was noted review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to the surgeon failing to follow instructions.As per the surgical technique, the warning states "use caution to avoid impacting the anti-rotational tabs on the rim of the implant." from the device return, the anti-rotational tab window has been impacted and bent down onto the locking ring tabs, preventing full movement of the locking ring.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information at the time of this report.

• Brand Name: TM ACET SHELL 52MM MULTI
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22937309
• Report Number: 0001822565-2025-03210
• Device Sequence Number: 9783742
• Product Code: LPH
• UDI-Device Identifier: 00889024118867
• UDI-Public: (01)00889024118867(17)350612(10)67285534
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00620205220
• Device Lot Number: 67285534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown